Pharmaceutical particulars : מידע רוקחי

   6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
L-arginine hydrochloride
Sodium citrate dihydrate
L-histidine
L-histidine monohydrochloride
Polysorbate 80
Citric acid monohydrate
Water for injections

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4    Special precautions for storage

Store in a refrigerator (2 °C-8 °C). Keep the pre-filled syringes or pre-filled pens in the outer carton in order to protect from light.
Do not freeze.

If needed, a single pre-filled syringe or pre-filled pen can be left out of the refrigerator protected from light at room temperature (up to 25 °C) for up to 7 days. Do not use the pre-filled syringe or pre-filled pen if left out of the refrigerator for more than 7 days.

6.5    Nature and contents of container

Entyvio 108 mg solution for injection in pre-filled syringe
Solution for injection in a Type I glass 1 mL syringe with a fixed 27 gauge thin wall, 1.27 cm needle.
The syringe has a rubber needle cover encased in a plastic shell and rubber stopper.
The subcutaneous vedolizumab pre-filled syringe is a single dose, disposable drug delivery system with manual injection operation. Each pre-filled syringe is equipped with a safety device that activates to extend and lock a guard over the needle once the injection is completed.

Packs of 1 or 2 pre-filled syringes, and multipacks of 6 (6 packs of 1) pre-filled syringes.

Entyvio 108 mg solution for injection in pre-filled pen
Solution for injection in a pre-filled pen in a Type I glass 1 mL syringe and a fixed 27 gauge thin wall, 1.27 cm needle. The syringe has a rubber needle cover encased in a plastic shell and rubber stopper.
The subcutaneous vedolizumab pre-filled pen is a single dose, disposable drug delivery system with mechanical injection operation. Each pre-filled pen is equipped with an automated needle shield to extend and lock over the needle once the device is removed from the injection site.

Packs of 1 or 2 pre-filled pens, and multipacks of 6 (6 packs of 1) pre-filled pens.

Not all pack sizes may be marketed.


6.6   Special precautions for disposal and other handling

Instructions for administration

After removing the pre-filled syringe or pre-filled pen from the refrigerator, wait 30 minutes before injecting to allow the solution to reach room temperature.

Do not leave the pre-filled syringe or pre-filled pen in direct sunlight.

Do not freeze. Do not use if it has been frozen.
Inspect the solution visually for particulate matter and discoloration prior to administration. The solution should be colourless to yellow. Do not use pre-filled syringe or pre-filled pen with visible particulate matter or discoloration.

Each pre-filled syringe or pre-filled pen is for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.